Trial Outcomes & Findings for Effects of Bupivacaine Induced Motor Blockade During the Second Stage of Labor (NCT NCT01621230)

Results Overview

The length of the second stage of labor (measured as minutes a parturient spends in Stage II) in nulliparous women received a epidural bupivacaine plus fentanyl or fentanyl alone.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

481 participants

Primary outcome timeframe

Duration of second stage of labor approximately 30 minutes to 150 minutes

Results posted on

2020-08-24

Participant Flow

A total of 1,013 women met the study inclusion criteria between September 7, 2009 and July 16, 2012 at Parkland Hospital. A total of 481 women were consented to participate in the study, and 310 women were randomized to receive the allotted study drug. The remaining women delivered without receiving an epidural.

171 women delivered prior to randomization at 8 cm cervical dilation.

Participant milestones

Participant milestones
Measure	Bupivacaine Plus Fentanyl Group I received bupivacaine plus fentanyl via epidural catheter during the second stage (i.e. 10 cm dilation) of labor via continuous epidural infusion of 10 cc/hr basal infusion plus 5 cc/hr demand dose via patient-controlled epidural analgesia (PCEA). Group I was allowed to receive meperidine 25 mg iv q1 hour for breakthrough pain.	Fentanyl Only Group II received a continuous infusion of fentanyl 10 mcg/cc at a basal infusion rate of 10 cc/hr with a patient-controlled epidural analgesia (PCEA) demand dose of 5 cc/hr for pain. Group II (like Group I) received meperidine 25 mg iv for breakthrough pain as needed.
Overall Study STARTED	154	156
Overall Study COMPLETED	154	156
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bupivacaine Plus Fentanyl n=154 Participants Group I received bupivacaine plus fentanyl via epidural catheter during the second stage (i.e. 10 cm dilation) of labor via continuous epidural infusion of 10 cc/hr basal infusion plus 5 cc/hr demand dose via patient-controlled epidural analgesia (PCEA). Group I was allowed to receive meperidine 25 mg iv q1 hour for breakthrough pain.	Fentanyl Only n=156 Participants Group II received a continuous infusion of fentanyl 10 mcg/cc at a basal infusion rate of 10 cc/hr with a patient-controlled epidural analgesia (PCEA) demand dose of 5 cc/hr for pain. Group II (like Group I) received meperidine 25 mg iv for breakthrough pain as needed.	Total n=310 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=154 Participants	0 Participants n=156 Participants	0 Participants n=310 Participants
Age, Categorical Between 18 and 65 years	154 Participants n=154 Participants	156 Participants n=156 Participants	310 Participants n=310 Participants
Age, Categorical >=65 years	0 Participants n=154 Participants	0 Participants n=156 Participants	0 Participants n=310 Participants
Age, Continuous	22.6 years STANDARD_DEVIATION 5.4 • n=154 Participants	22.9 years STANDARD_DEVIATION 5.0 • n=156 Participants	22.7 years STANDARD_DEVIATION 5.2 • n=310 Participants
Sex: Female, Male Female	154 Participants n=154 Participants	156 Participants n=156 Participants	310 Participants n=310 Participants
Sex: Female, Male Male	0 Participants n=154 Participants	0 Participants n=156 Participants	0 Participants n=310 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	154 participants n=154 Participants	156 participants n=156 Participants	310 participants n=310 Participants

PRIMARY outcome

Timeframe: Duration of second stage of labor approximately 30 minutes to 150 minutes

The length of the second stage of labor (measured as minutes a parturient spends in Stage II) in nulliparous women received a epidural bupivacaine plus fentanyl or fentanyl alone.

Outcome measures

Outcome measures
Measure	Group I (Bupivacaine) n=154 Participants Group I received bupivacaine plus fentanyl via epidural catheter during the second stage (i.e. 10 cm dilation) of labor via continuous epidural infusion of 10 cc/hr basal infusion plus 5 cc/hr demand dose via patient-controlled epidural analgesia (PCEA). Group I was allowed to receive meperidine 25 mg iv q1 hour for breakthrough pain.	Group II (No Bupivacaine) n=156 Participants Group II received a continuous infusion of fentanyl 10 mcg/cc at a basal infusion rate of 10 cc/hr with a patient-controlled epidural analgesia (PCEA) demand dose of 5 cc/hr for pain. Group II (like Group I) received meperidine 25 mg iv for breakthrough pain as needed.
The Duration of the Second Stage of Labor	75 minutes Interval 41.0 to 128.0	73 minutes Interval 42.0 to 120.0

SECONDARY outcome

Timeframe: Duration of second stage of labor approximately 30 minutes to 150 minutes

Population: PI for this study is deceased and the relevant data have been destroyed. The underlying data are not available for accurately reporting the information in this Outcome Measure

Motor blockade will be estimated using Bromage and Breen scores (measured on a 6-point standardized scale, 1= Unable to more feet, 6= Able to perform partial knee bend) that estimate motor blockade. This scoring system is based upon the laboring womans' ability to move her lower extremities.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At the time of Delivery

Outcome measures

Outcome measures
Measure	Group I (Bupivacaine) n=156 Participants Group I received bupivacaine plus fentanyl via epidural catheter during the second stage (i.e. 10 cm dilation) of labor via continuous epidural infusion of 10 cc/hr basal infusion plus 5 cc/hr demand dose via patient-controlled epidural analgesia (PCEA). Group I was allowed to receive meperidine 25 mg iv q1 hour for breakthrough pain.	Group II (No Bupivacaine) n=154 Participants Group II received a continuous infusion of fentanyl 10 mcg/cc at a basal infusion rate of 10 cc/hr with a patient-controlled epidural analgesia (PCEA) demand dose of 5 cc/hr for pain. Group II (like Group I) received meperidine 25 mg iv for breakthrough pain as needed.
Mode of Delivery in Women Randomized to Bupivacaine vs. No Bupivacaine During the Second Stage of Labor Spontaneous	126 Participants	112 Participants
Mode of Delivery in Women Randomized to Bupivacaine vs. No Bupivacaine During the Second Stage of Labor Forceps-assisted	12 Participants	19 Participants
Mode of Delivery in Women Randomized to Bupivacaine vs. No Bupivacaine During the Second Stage of Labor Cesarean	18 Participants	23 Participants

SECONDARY outcome

Timeframe: At the time of Delivery, up to 3 hours

Number of participants whose newborns received an APGAR score of \<=3 at 1 min. A lower APGAR score represents poor health or a worsening in the Outcome,

Outcome measures

Outcome measures
Measure	Group I (Bupivacaine) n=156 Participants Group I received bupivacaine plus fentanyl via epidural catheter during the second stage (i.e. 10 cm dilation) of labor via continuous epidural infusion of 10 cc/hr basal infusion plus 5 cc/hr demand dose via patient-controlled epidural analgesia (PCEA). Group I was allowed to receive meperidine 25 mg iv q1 hour for breakthrough pain.	Group II (No Bupivacaine) n=154 Participants Group II received a continuous infusion of fentanyl 10 mcg/cc at a basal infusion rate of 10 cc/hr with a patient-controlled epidural analgesia (PCEA) demand dose of 5 cc/hr for pain. Group II (like Group I) received meperidine 25 mg iv for breakthrough pain as needed.
Number of Participants Whose Newborns Received an APGAR Score of <=3 at 1 Min	14 Participants	11 Participants

SECONDARY outcome

Timeframe: At the time of Delivery, up to 3 hours

Number of participants whose newborns received an APGAR score of \<=3 at 5 minutes. A lower APGAR score represents poor health or a worsening in the Outcome

Outcome measures

Outcome measures
Measure	Group I (Bupivacaine) n=156 Participants Group I received bupivacaine plus fentanyl via epidural catheter during the second stage (i.e. 10 cm dilation) of labor via continuous epidural infusion of 10 cc/hr basal infusion plus 5 cc/hr demand dose via patient-controlled epidural analgesia (PCEA). Group I was allowed to receive meperidine 25 mg iv q1 hour for breakthrough pain.	Group II (No Bupivacaine) n=154 Participants Group II received a continuous infusion of fentanyl 10 mcg/cc at a basal infusion rate of 10 cc/hr with a patient-controlled epidural analgesia (PCEA) demand dose of 5 cc/hr for pain. Group II (like Group I) received meperidine 25 mg iv for breakthrough pain as needed.
Number of Participants Whose Newborns Received an APGAR Score of <=3 at 5 Min	2 Participants	1 Participants

Adverse Events

Bupivacaine Plus Fentanyl

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fentanyl Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Margaret Craig, MD

UTexasSouthwestern

Phone: 2142638919

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place